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China has implemented a new policy for initially imported non-special use cosmetics through Shanghai Pudong New Area. The cosmetics will only require filing with Shanghai FDA instead of registration with CFDA from Mar 1 2017 to Dec 21 2018. According to the detailed guidance released by CFDA on Jan 18 , the FDA will grant a filing certificate to the applicant after a priliminary review of application dossiers, then the applicant can start to import. This new policy offers international companies dealing in non-special use cosmetics a fast channel to enter into Chinese market. Now CFDA plans to expand the practice of imported non-special use cosmetics filing management in Pudong to other 10 FTZs...

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  • China to Extend First-Imported Non-special Cosmetic Filing Management Scheme to Ten Ports
    Takehome: In an internal conference CFDA outlined plans to expand the Shanghai Pudong first-imported, non-special cosmetic filing management scheme to a total of ten ports.
  • Filing Management for Imported Non-special Cosmetics Expanded to Sichuan and Fujian
    Takehome: The success of the Pudong imported, non-special cosmetic filing system has prompted government to expand the system to other provinces. Sichuan and Fujian now offer filing for imported non-special cosmetics until Dec.21st 2018. Like the Pudong system this will mean that eligible cosmetics imported through these areas will not require registration. Fujian first launched this trial on Dec.18th 2017 Areas in Fujian for Filing Management of First Non-imported Cosmetics
  • Zhejiang Zhoushan Be the Next Place to Offer Imported Non-Special Cosmetics Filing Management
    Takehome: CFDA plans to expand the practice of imported non-special use cosmetics filing management in Pudong to other 10 FTZs. Zhejiang Zhoushan has been selected as the next location and has already undergone preliminary feasibility and capacity assessment.
  • Shanghai FDA Outlines Problems in Implementation of Pudong Cosmetic Filing
    Takehome: Shanghai FDA has outlined some problems in the implementation of the Pudong cosmetic filing management pilot program, specifically issues relating to responsible person requirements.   The main issue related to Responsible Person (for first import non-special use cosmetics) is that the address which was filled online is often different from the address used on-site. SHFDA regard it as the RP filling out false information, and the RP will be subject to certain punishment pursuant to relevant requirements in “Credibility Surveillance”.
  • Filing Management for Non-special Imported Cosmetics: Shanghai FDA Clarify Dossier Preparation
    Take home: Shanghai Pudong has implemented filing management for first imported non-special use cosmetics for almost half a year (See News on CL). According to the latest data, 202 types of products have successfully filed a record (data resourced from CFDA). Although the pass rate is high, plenty of problems occurred during technical review. Therefore, Shanghai FDA has clarified dossier preparation instructions. Q1: How to define “imported” cosmetics for OEM companies? A1: For enterprises who entrust a 3rd party manufacturer to manufacture cosmetics, if the last production procedure is completed abroad, then the product is subject to imported cosmetic requirements. For example, if the product is prepared and manufactured in China but encapsulated abroad, it is an imported cosmetic. Q2: How to provide “testing report” for Pudong imported non-special use cosmetics filing management? A2: The testing report for filing management should meet the same requirement as cosmetic registration. In this situation, when recording the information, the “responsible person” should be filled out in the blank for “responsible agent” and followed by the sentence “here refers to responsible person”. If an imported non-special cosmetic has completed the testing report for registration, the report can be also be used for Pudong filing management. In this situation, if the original responsible agent for the report is different from newly designated responsible person, the applicant should provide documentary evidence to prove that the product applying for filing management is the same as the one used to obtain the testing report, and submit an acknowledgement letter from the original responsible agent to permit the use of the testing report. Q3: Can imported non-special children cosmetics go through Pudong filing management?
  • China Release Testing Report Requirement to Support Pudong Imported Non-special Cosmetics Filing Management System
    Take home: CFDA released instruction on how to generate testing report for Pudong filing management system, and guaranteed that finished testing report for registration can be used for filing management; Non-special use cosmetics of Shanghai local enterprises who entrust foreign manufacturers to complete the last procedure are designated as imported cosmetics, and can apply for import non-special use cosmetics filing certificate. Those enterprises don’t require a “responsible person” The testing institution should generate testing report in compliance with ‘Standard of Testing for Cosmetic Registration ’. For Pudong filing system, applicants should put the information of “responsible person” in the blank for “responsible agent”, and meanwhile mark it as “responsible person” after “agent name”.

Comparison between Pudong Filing and CFDA Licensing

 Pudong FilingCFDA Licensing
Supervision After submit the filling files by the responsible person and get the electronic certificate, the cosmetics are allowed to import. Import cosmetics are allowed to import after the application approved by the CFDA.
Safety requirement

Requirements are same

The filing aims at adjusting the supervision mode without lower the requirements for product safety.

Dossier requirements
Requirements are same
Product testing

Requirements are same

The filing also requires toxicology testing including animal testing.

Safety assessment
Requirements are same
Authorization

Requirements are same

Oversea cosmetic manufacturers authorize a domestic entity to be the responsible agent/person, and clarify the scope and period of authority by signing the <Power of Attorney>

Responsible agent/person

1. The domestic responsible person should be a business entity located in Shanghai Pudong New Area.

2. The person is responsible for importation, operation and safety of the product, including appointing a specialist for quality and safety management, building product safety management, traceability and adverse effect reporting systems and recalling products.

3. One oversea cosmetic manufacturer can appoint more than one responsible person in China. But one product can only have one domestic responsible person.

1. The responsible agent should be an independent legal personality registrated in China.

2. The responsible agent in China is only responsible for the registration.

3. One oversea cosmetic manufacturer can only appoint one responsible agent in China.

Required timeAfter one week of a priliminary review of application dossiers, cosmetics can be imported if approved.Three to four months

Filing Process

process

Experts Say

  • Eliza Li | REACH24H

    Non-special products especially baby products and season-specific products can choose to take full use of Pudong trial to enjoy its flexibility. But stakeholders should keep in mind that although filing management apparently shortens the review time, it doesn’t reduce control of product quality and safety, sometimes it can be even stricter...[more]

  • Kathy Lou | REACH24H

    The CFDA licensing and Pudong filing can’t be applied for simultaneously. For products already obtained Pudong filing certificate, if the applicant wants to import products from other ports rather than Pudong, he shall cancel the certificate first. If products have been disapproved by CFDA, Pudong filing is not applicable.

  • Vian Fang | REACH24H

    The standards for cosmetic safety evaluation are changing constantly. Cosmetic companies can keep track of the most recent compliance requirements and review comments on products in the process of filing on the Pudong filing system.

  • Nina He | REACH24H

    Pudong filing requires more qualifications for the responsible person who shall have a real office (not only the registered office) with quality management staff and capability of cosmetic importation.

  • Marylene Zhan | REACH24H

    The preliminary review conducted by Shanghai FDA is actually stricter than CFDA's review. Some comments are even not proposed by CFDA before.

  • Inna Fu | REACH24H

    It should be noted that the paper dossiers shall be exactly the same as the e-dossiers submitted online, even the position of stamps.

Consultation

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